Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Dermatomyositis (Connective Tissue Disease)
Idiopathic Inflammatory Myopathies
Treatment
ABC008
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult males and females age >40 years at the time of the first dose of studymedication;
Weight >40 and <150 kg;
Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, orprobable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 researchdiagnostic criteria (Rose et al., 2013). Documented histopathology results must beavailable prior to Baseline (Day 1) to confirm eligibility;
Able to arise from a chair (with armrests), with use of their arms but withoutsupport from another person or device (e.g., cane, walking stick), at Screening andBaseline (Day 1);
Able to walk 3 meters, turn around, walk back to the chair, and sit down, with orwithout assistive device. Once arisen from the chair, subject may use any walkingdevice but cannot be supported by another person, furniture, or a wall;
Exclusion
Exclusion Criteria:
Any other form of myositis or myopathy other than IBM, e.g., metabolic ordrug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositisor dermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years,either before or after), myositis in overlap with another autoimmune disease (e.g.,systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy;
Any condition, e.g., severe degenerative arthritis with limited range of motion,which precludes the ability to quantitate muscle strength or perform functionalassessments (e.g., mTUG), in the Investigator's opinion;.
Presence of another autoimmune or autoinflammatory disease other than indicationunder study, e.g., rheumatoid arthritis, psoriatic arthritis, axialspondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus.Subjects with Sjogren's syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted;
Study Design
Study Description
Connect with a study center
Royal North Shore Hospital
Saint Leonards, New South Wales 2155400 2065
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Herston, Queensland 4006
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Herston 6931014, Queensland 2152274 4006
AustraliaSite Not Available
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia 6009
AustraliaSite Not Available
Perron Institute for Neurological and Translational Science
Nedlands 2064874, Western Australia 2058645 6009
AustraliaSite Not Available
AZ Sint-Lucas & Volkskliniek
Gent, 9000
BelgiumSite Not Available
AZ Sint-Lucas & Volkskliniek
Ghent 2797656, 9000
BelgiumSite Not Available
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta 3M 1M4
CanadaSite Not Available
Heritage Medical Research Clinic - University of Calgary
Calgary 5913490, Alberta 5883102 3M 1M4
CanadaSite Not Available
Genge Partners Inc.
Montréal, Quebec H4A 3T2
CanadaSite Not Available
Genge Partners Inc.
Montreal 6077243, Quebec 6115047 H4A 3T2
CanadaSite Not Available
Hospital Pitie-Salpetriere - AP-HP
Paris, 75013
FranceSite Not Available
Hospital Pitie-Salpetriere - AP-HP
Paris 2988507, 75013
FranceSite Not Available
Krankenhaus und Poliklinik Rüdersdorf GmbH
Berlin, 15562
GermanySite Not Available
Krankenhaus und Poliklinik Rüdersdorf GmbH
Berlin 2950159, 15562
GermanySite Not Available
University Hosptial Duesseldorf
Düsseldorf, 40225
GermanySite Not Available
University Hosptial Duesseldorf
Düsseldorf 2934246, 40225
GermanySite Not Available
University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)
London, WC1N 3BG
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)
London 2643743, WC1N 3BG
United KingdomSite Not Available
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, M6 8HD
United KingdomSite Not Available
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford 2638671, M6 8HD
United KingdomSite Not Available
Neuromuscular Research Center
Phoenix, Arizona 85028
United StatesSite Not Available
Neuromuscular Research Center
Phoenix 5308655, Arizona 5551752 85028
United StatesSite Not Available
University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
Irvine, California 92868
United StatesSite Not Available
Keck Hosptial of USC
Los Angeles, California 90033
United StatesSite Not Available
UCLA Medical Center
Los Angeles, California 90095
United StatesSite Not Available
Stanford Neuroscience Medical Center
Palo Alto, California 94304
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
Irvine 5359777, California 5332921 92868
United StatesSite Not Available
Keck Hosptial of USC
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
UCLA Medical Center
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Stanford Neuroscience Medical Center
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
University of California, San Francisco
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
University of Colorado Hospital Anschutz Outpatient Pavillion
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Hospital Anschutz Outpatient Pavillion
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06519
United StatesSite Not Available
Yale School of Medicine
New Haven 4839366, Connecticut 4831725 06519
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Northwestern Memorial Hospital, Department of Neurology (Clinic)
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern Memorial Hospital, Department of Neurology (Clinic)
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
University of Kansas Medical
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Bayview Medical Center
Baltimore 4347778, Maryland 4361885 21224
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 021158
United StatesSite Not Available
Neuromuscular Diagnostic Center - Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 021158
United StatesSite Not Available
Neuromuscular Diagnostic Center - Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 98198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 98198
United StatesSite Not Available
Columbia University Medical Center / The Neurological Institute of New York
New York, New York 10032
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Hospital for Special Surgery
New York City, New York 10021
United StatesSite Not Available
Columbia University Medical Center / The Neurological Institute of New York
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Hospital for Special Surgery
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Duke Neurological Disorders Clinic -1L
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forrest School of Medicine
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Duke Neurological Disorders Clinic -1L
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Wake Forrest School of Medicine
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburg, Pennsylvania 15213
United StatesSite Not Available
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Austin Neuromuscular Center
Austin, Texas 78759
United StatesSite Not Available
Texas Neurology
Dallas, Texas 75206
United StatesSite Not Available
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesSite Not Available
Austin Neuromuscular Center
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Texas Neurology
Dallas 4684888, Texas 4736286 75206
United StatesSite Not Available
Nerve and Muscle Center of Texas
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Virginia Commonwealth University
Henrico, Virginia 23233
United StatesSite Not Available
Virginia Commonwealth University
Henrico 4763729, Virginia 6254928 23233
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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